Product Code: FSA FDA class 1 21 CFR 880.5510

Lift, Patient, Non-Ac-Powered

General Hospital

A non-AC-powered patient lift is a manually or hydraulically operated device used to lift and transfer patients who have limited or no mobility, commonly used in hospital and long-term care settings. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FSA, regulated under 21 CFR 880.5510, within the General Hospital medical specialty. No special flags apply to this device.

510(k)s
13
FEI Numbers
206
Registration Numbers
207
Unique Applicants
12
Years Active
16

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Basic Information

Product Code
FSA
Device Class
FDA class 1
Regulation Number
880.5510
Medical Specialty
General Hospital
Review Panel
HO
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 13 510(k) clearances via K numbers.

K Number Device Name
K942807 SURGICAL LIFT SHEET
K930625 SANITAS PATIENT LIFT
K902141 ANOLIFT - PORTABLE & ANOLIFT - GANTRY
K860837 HOYER ONE-TOUCH POWER LIFTER
K851844 MOLIFT
K844976 MEDI-MAN WATER POWERED BATH LIFT & HYDRAULIC LIFT
K841398 VARIABLE HEIGHT TRANSFER CHAIR
K841395 SHOWER TROLLEY
K840997 BATTERY POWERED PATIENT LIFT
K823206 MARTIN PELVIC LIFT
K811899 CENTURY LIFT TRANSFER SYSTEM
K792601 LIFELIFT MODELS ONE AND TWO
K780684 PATIENT LIFT

FEI Numbers

This FDA classification entry is associated with 206 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 207 registration numbers. Click on an entry to view related FDA registrations.